© 2000 by Oxford University Press
Journal of the National Cancer Institute, Vol. 92, No. 3, 205-216,
February 2, 2000
© 2000 Oxford University Press
SPECIAL ARTICLE |
New Guidelines to Evaluate the Response to Treatment in Solid Tumors
Affiliations of authors: P. Therasse, J. Verweij, M. Van Glabbeke, A. T. van Oosterom, European Organization for Research and Treatment of Cancer, Brussels, Belgium; S. G. Arbuck, R. S. Kaplan, L. Rubinstein, M. C. Christian, National Cancer Institute, Bethesda, MD; E. A. Eisenhauer, National Cancer Institute of Canada Clinical Trials Group, Kingston, ON, Canada; J. Wanders, New Drug Development Office Oncology, Amsterdam, The Netherlands; S. G. Gwyther, East Surrey Healthcare National Health Service Trust, Redhill, U.K.
Correspondence to: Patrick Therasse, M.D., European Organization for Research and Treatment of Cancer Data Center, Avenue Mounier 83/11, 1200 Brussels, Belgium (e-mail: pth{at}eortc.be).
Anticancer cytotoxic agents go through a process by which their antitumor activity—on the basis of the amount of tumor shrinkage they could generate—has been investigated. In the late 1970s, the International Union Against Cancer and the World Health Organization introduced specific criteria for the codification of tumor response evaluation. In 1994, several organizations involved in clinical research combined forces to tackle the review of these criteria on the basis of the experience and knowledge acquired since then. After several years of intensive discussions, a new set of guidelines is ready that will supersede the former criteria. In parallel to this initiative, one of the participating groups developed a model by which response rates could be derived from unidimensional measurement of tumor lesions instead of the usual bidimensional approach. This new concept has been largely validated by the Response Evaluation Criteria in Solid Tumors Group and integrated into the present guidelines. This special article also provides some philosophic background to clarify the various purposes of response evaluation. It proposes a model by which a combined assessment of all existing lesions, characterized by target lesions (to be measured) and nontarget lesions, is used to extrapolate an overall response to treatment. Methods of assessing tumor lesions are better codified, briefly within the guidelines and in more detail in Appendix I. All other aspects of response evaluation have been discussed, reviewed, and amended whenever appropriate.
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- Re: New Guidelines to Evaluate the Response to Treatment in Solid Tumors [Ovarian Cancer]
- Ignace Vergote, Gordon J. S. Rustin, Elisabeth A. Eisenhauer, Gunnar B. Kristensen, Eric Pujade-Lauraine, Mahesh K. B. Parmar, Michael Friedlander, Anders Jakobsen, and Jan B. Vermorken
J Natl Cancer Inst 2000 92: 1534-1535.[Extract] [Full Text] [PDF]
- Re: New Guidelines to Evaluate the Response to Treatment in Solid Tumors (Ovarian Cancer)
- Gordon J. S. Rustin, Michael Quinn, Tate Thigpen, Andreas du Bois, Eric Pujade-Lauraine, Anders Jakobsen, Elizabeth Eisenhauer, Satoru Sagae, Kathryn Greven, Ignace Vergote, Andres Cervantes, and Jan Vermorken
J Natl Cancer Inst 2004 96: 487-488.[Extract] [Full Text] [PDF]
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J. A. Sparano, A. N. Makhson, V. F. Semiglazov, S. A. Tjulandin, O. I. Balashova, I. N. Bondarenko, N. V. Bogdanova, G. M. Manikhas, G. P. Oliynychenko, V. A. Chatikhine, et al. Pegylated Liposomal Doxorubicin Plus Docetaxel Significantly Improves Time to Progression Without Additive Cardiotoxicity Compared With Docetaxel Monotherapy in Patients With Advanced Breast Cancer Previously Treated With Neoadjuvant-Adjuvant Anthracycline Therapy: Results From a Randomized Phase III Study J. Clin. Oncol., September 20, 2009; 27(27): 4522 - 4529. [Abstract] [Full Text] [PDF]
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J. Bellmunt, C. Theodore, T. Demkov, B. Komyakov, L. Sengelov, G. Daugaard, A. Caty, J. Carles, A. Jagiello-Gruszfeld, O. Karyakin, et al. Phase III Trial of Vinflunine Plus Best Supportive Care Compared With Best Supportive Care Alone After a Platinum-Containing Regimen in Patients With Advanced Transitional Cell Carcinoma of the Urothelial Tract J. Clin. Oncol., September 20, 2009; 27(27): 4454 - 4461. [Abstract] [Full Text] [PDF]
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G. Giaccone, P. Zatloukal, J. Roubec, K. Floor, J. Musil, M. Kuta, R. J. van Klaveren, S. Chaudhary, A. Gunther, and S. Shamsili Multicenter Phase II Trial of YM155, a Small-Molecule Suppressor of Survivin, in Patients With Advanced, Refractory, Non-Small-Cell Lung Cancer J. Clin. Oncol., September 20, 2009; 27(27): 4481 - 4486. [Abstract] [Full Text] [PDF]
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S. L. Ellard, M. Clemons, K. A. Gelmon, B. Norris, H. Kennecke, S. Chia, K. Pritchard, A. Eisen, T. Vandenberg, M. Taylor, et al. Randomized Phase II Study Comparing Two Schedules of Everolimus in Patients With Recurrent/Metastatic Breast Cancer: NCIC Clinical Trials Group IND.163 J. Clin. Oncol., September 20, 2009; 27(27): 4536 - 4541. [Abstract] [Full Text] [PDF]
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G. D. Demetri, P. G. Casali, J.-Y. Blay, M. von Mehren, J. A. Morgan, R. Bertulli, I. Ray-Coquard, P. Cassier, M. Davey, H. Borghaei, et al. A Phase I Study of Single-Agent Nilotinib or in Combination with Imatinib in Patients with Imatinib-Resistant Gastrointestinal Stromal Tumors Clin. Cancer Res., September 15, 2009; 15(18): 5910 - 5916. [Abstract] [Full Text] [PDF]
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G. D. Demetri, M. C. Heinrich, J. A. Fletcher, C. D.M. Fletcher, A. D. Van den Abbeele, C. L. Corless, C. R. Antonescu, S. George, J. A. Morgan, M. H. Chen, et al. Molecular Target Modulation, Imaging, and Clinical Evaluation of Gastrointestinal Stromal Tumor Patients Treated with Sunitinib Malate after Imatinib Failure Clin. Cancer Res., September 15, 2009; 15(18): 5902 - 5909. [Abstract] [Full Text] [PDF]
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S. E. DePrimo, X. Huang, M. E. Blackstein, C. R. Garrett, C. S. Harmon, P. Schoffski, M. H. Shah, J. Verweij, C. M. Baum, and G. D. Demetri Circulating Levels of Soluble KIT Serve as a Biomarker for Clinical Outcome in Gastrointestinal Stromal Tumor Patients Receiving Sunitinib following Imatinib Failure Clin. Cancer Res., September 15, 2009; 15(18): 5869 - 5877. [Abstract] [Full Text] [PDF]
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T. Bekaii-Saab, J. Markowitz, N. Prescott, W. Sadee, N. Heerema, L. Wei, Z. Dai, A. Papp, A. Campbell, K. Culler, et al. A Multi-Institutional Phase II Study of the Efficacy and Tolerability of Lapatinib in Patients with Advanced Hepatocellular Carcinomas Clin. Cancer Res., September 15, 2009; 15(18): 5895 - 5901. [Abstract] [Full Text] [PDF]
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M. K. Chung, H.-S. Jeong, S. G. Park, J. Y. Jang, Y.-I. Son, J. Y. Choi, S. H. Hyun, K. Park, M.-J. Ahn, Y. C. Ahn, et al. Metabolic Tumor Volume of [18F]-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography Predicts Short-Term Outcome to Radiotherapy With or Without Chemotherapy in Pharyngeal Cancer Clin. Cancer Res., September 15, 2009; 15(18): 5861 - 5868. [Abstract] [Full Text] [PDF]
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G. R. Blumenschein Jr, U. Gatzemeier, F. Fossella, D. J. Stewart, L. Cupit, F. Cihon, J. O'Leary, and M. Reck Phase II, Multicenter, Uncontrolled Trial of Single-Agent Sorafenib in Patients With Relapsed or Refractory, Advanced Non-Small-Cell Lung Cancer J. Clin. Oncol., September 10, 2009; 27(26): 4274 - 4280. [Abstract] [Full Text] [PDF]
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A. T. Shaw, B. Y. Yeap, M. Mino-Kenudson, S. R. Digumarthy, D. B. Costa, R. S. Heist, B. Solomon, H. Stubbs, S. Admane, U. McDermott, et al. Clinical Features and Outcome of Patients With Non-Small-Cell Lung Cancer Who Harbor EML4-ALK J. Clin. Oncol., September 10, 2009; 27(26): 4247 - 4253. [Abstract] [Full Text] [PDF]
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T. S. Mok, Y.-L. Wu, S. Thongprasert, C.-H. Yang, D.-T. Chu, N. Saijo, P. Sunpaweravong, B. Han, B. Margono, Y. Ichinose, et al. Gefitinib or Carboplatin-Paclitaxel in Pulmonary Adenocarcinoma N. Engl. J. Med., September 3, 2009; 361(10): 947 - 957. [Abstract] [Full Text] [PDF]
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W. Fenske, H.-U. Volker, P. Adam, S. Hahner, S. Johanssen, S. Wortmann, M. Schmidt, M. Morcos, H.-K. Muller-Hermelink, B. Allolio, et al. Glucose transporter GLUT1 expression is an stage-independent predictor of clinical outcome in adrenocortical carcinoma Endocr. Relat. Cancer, September 1, 2009; 16(3): 919 - 928. [Abstract] [Full Text] [PDF]
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R Srirajaskanthan, G Dancey, A Hackshaw, T Luong, M E Caplin, and T Meyer Circulating angiopoietin-2 is elevated in patients with neuroendocrine tumours and correlates with disease burden and prognosis Endocr. Relat. Cancer, September 1, 2009; 16(3): 967 - 976. [Abstract] [Full Text] [PDF]
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Y. H. Kim, K. Kubota, K. Goto, K. Yoh, S. Niho, H. Ohmatsu, N. Saijo, and Y. Nishiwaki A Phase I Study of Gemcitabine and Carboplatin in Patients with Advanced Non-small Cell Lung Cancer and a Performance Status of 2 Jpn. J. Clin. Oncol., September 1, 2009; 39(9): 576 - 581. [Abstract] [Full Text] [PDF]
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H. Ishida, Y. Miyake, M. Fukunaga, Y. Watanabe, T. Kato, H. Takemoto, and H. Furukawa A Feasibility Study of UFT/LV and Irinotecan (TEGAFIRI) in Advanced or Metastatic Colorectal Cancer: Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) PROG 0304 Jpn. J. Clin. Oncol., September 1, 2009; 39(9): 601 - 605. [Abstract] [Full Text] [PDF]
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S. Gonias, R. Goldsby, K. K. Matthay, R. Hawkins, D. Price, J. Huberty, L. Damon, C. Linker, A. Sznewajs, S. Shiboski, et al. Phase II Study of High-Dose [131I]Metaiodobenzylguanidine Therapy for Patients With Metastatic Pheochromocytoma and Paraganglioma J. Clin. Oncol., September 1, 2009; 27(25): 4162 - 4168. [Abstract] [Full Text] [PDF]
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F. A.L.M. Eskens, N. Steeghs, J. Verweij, J. L. Bloem, O. Christensen, L. van Doorn, J. Ouwerkerk, M. J.A. de Jonge, J. W.R. Nortier, J. Kraetzschmar, et al. Phase I Dose Escalation Study of Telatinib, a Tyrosine Kinase Inhibitor of Vascular Endothelial Growth Factor Receptor 2 and 3, Platelet-Derived Growth Factor Receptor {beta}, and c-Kit, in Patients With Advanced or Metastatic Solid Tumors J. Clin. Oncol., September 1, 2009; 27(25): 4169 - 4176. [Abstract] [Full Text] [PDF]
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B. Escudier, J. Roigas, S. Gillessen, U. Harmenberg, S. Srinivas, S. F. Mulder, G. Fountzilas, C. Peschel, P. Flodgren, E. C. Maneval, et al. Phase II Study of Sunitinib Administered in a Continuous Once-Daily Dosing Regimen in Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma J. Clin. Oncol., September 1, 2009; 27(25): 4068 - 4075. [Abstract] [Full Text] [PDF]
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G. A. van Hazel, N. Pavlakis, D. Goldstein, I. N. Olver, M. J. Tapner, D. Price, G. D. Bower, G. M. Briggs, M. A. Rossleigh, D. J. Taylor, et al. Treatment of Fluorouracil-Refractory Patients With Liver Metastases From Colorectal Cancer by Using Yttrium-90 Resin Microspheres Plus Concomitant Systemic Irinotecan Chemotherapy J. Clin. Oncol., September 1, 2009; 27(25): 4089 - 4095. [Abstract] [Full Text] [PDF]
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G. D. Demetri, S. P. Chawla, M. von Mehren, P. Ritch, L. H. Baker, J. Y. Blay, K. R. Hande, M. L. Keohan, B. L. Samuels, S. Schuetze, et al. Efficacy and Safety of Trabectedin in Patients With Advanced or Metastatic Liposarcoma or Leiomyosarcoma After Failure of Prior Anthracyclines and Ifosfamide: Results of a Randomized Phase II Study of Two Different Schedules J. Clin. Oncol., September 1, 2009; 27(25): 4188 - 4196. [Abstract] [Full Text] [PDF]
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B. Rikhof, J. van Doorn, A. J. H. Suurmeijer, M. W. Rautenberg, P. J. T. A. Groenen, M. A. J. Verdijk, P. L. Jager, S. de Jong, J. A. Gietema, and W. T. A. van der Graaf Insulin-like growth factors and insulin-like growth factor-binding proteins in relation to disease status and incidence of hypoglycaemia in patients with a gastrointestinal stromal tumour Ann. Onc., September 1, 2009; 20(9): 1582 - 1588. [Abstract] [Full Text] [PDF]
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A. F. C. Okines, A. R. Norman, P. McCloud, Y.-K. Kang, and D. Cunningham Meta-analysis of the REAL-2 and ML17032 trials: evaluating capecitabine-based combination chemotherapy and infused 5-fluorouracil-based combination chemotherapy for the treatment of advanced oesophago-gastric cancer Ann. Onc., September 1, 2009; 20(9): 1529 - 1534. [Abstract] [Full Text] [PDF]
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A.-R. Hanauske, M. Lahn, L. C. Musib, K. Weigang-Kohler, E. Yilmaz, T. Graefe, B. Kuenen, D. Thornton, P. McNealy, and G. Giaccone Phase Ib safety and pharmacokinetic evaluation of daily and twice daily oral enzastaurin in combination with pemetrexed in advanced/metastatic cancer Ann. Onc., September 1, 2009; 20(9): 1565 - 1575. [Abstract] [Full Text] [PDF]
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W. R. Jarnagin, L. H. Schwartz, D. H. Gultekin, M. Gonen, D. Haviland, J. Shia, M. D'Angelica, Y. Fong, R. DeMatteo, A. Tse, et al. Regional chemotherapy for unresectable primary liver cancer: results of a phase II clinical trial and assessment of DCE-MRI as a biomarker of survival Ann. Onc., September 1, 2009; 20(9): 1589 - 1595. [Abstract] [Full Text] [PDF]
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M. Gabriel, A. Oberauer, G. Dobrozemsky, C. Decristoforo, D. Putzer, D. Kendler, C. Uprimny, P. Kovacs, R. Bale, and I. J. Virgolini 68Ga-DOTA-Tyr3-Octreotide PET for Assessing Response to Somatostatin-Receptor-Mediated Radionuclide Therapy J. Nucl. Med., September 1, 2009; 50(9): 1427 - 1434. [Abstract] [Full Text] [PDF]
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C. H. Mom, J. Verweij, C. N.A.M. Oldenhuis, J. A. Gietema, N. L. Fox, R. Miceli, F. A.L.M. Eskens, W. J. Loos, E. G.E. de Vries, and S. Sleijfer Mapatumumab, a Fully Human Agonistic Monoclonal Antibody That Targets TRAIL-R1, in Combination with Gemcitabine and Cisplatin: a Phase I Study Clin. Cancer Res., September 1, 2009; 15(17): 5584 - 5590. [Abstract] [Full Text] [PDF]
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A. J. Chien, J. A. Illi, A. H. Ko, W. M. Korn, L. Fong, L.-m. Chen, M. Kashani-Sabet, C. J. Ryan, J. E. Rosenberg, S. Dubey, et al. A Phase I Study of a 2-Day Lapatinib Chemosensitization Pulse Preceding Nanoparticle Albumin-Bound Paclitaxel for Advanced Solid Malignancies Clin. Cancer Res., September 1, 2009; 15(17): 5569 - 5575. [Abstract] [Full Text] [PDF]
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 C. Gridelli, A. Rossi, P. Maione, M. L. Ferrara, V. Castaldo, and P. C. Sacco Vaccines for the Treatment of Non-Small Cell Lung Cancer: A Renewed Anticancer Strategy Oncologist, September 1, 2009; 14(9): 909 - 920. [Abstract] [Full Text] [PDF]
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M. H. Cohen, R. Justice, and R. Pazdur Approval Summary: Pemetrexed in the Initial Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer Oncologist, September 1, 2009; 14(9): 930 - 935. [Abstract] [Full Text] [PDF]
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C.-H. Chen, C.-H. Kang, and P.-H. Chiang Intra-arterial Infusion of Chemotherapy in the Treatment of Penile Cancer Jpn. J. Clin. Oncol., August 27, 2009; (2009) hyp101v1. [Abstract] [Full Text] [PDF]
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C. A. Klebanoff, Z. Yu, L. N. Hwang, D. C. Palmer, L. Gattinoni, and N. P. Restifo Programming tumor-reactive effector memory CD8+ T cells in vitro obviates the requirement for in vivo vaccination Blood, August 27, 2009; 114(9): 1776 - 1783. [Abstract] [Full Text] [PDF]
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A. Le Cesne, M. Van Glabbeke, J. Verweij, P. G. Casali, M. Findlay, P. Reichardt, R. Issels, I. Judson, P. Schoffski, S. Leyvraz, et al. Absence of Progression As Assessed by Response Evaluation Criteria in Solid Tumors Predicts Survival in Advanced GI Stromal Tumors Treated With Imatinib Mesylate: The Intergroup EORTC-ISG-AGITG Phase III Trial J. Clin. Oncol., August 20, 2009; 27(24): 3969 - 3974. [Abstract] [Full Text] [PDF]
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G. Attard, A. H.M. Reid, R. A'Hern, C. Parker, N. B. Oommen, E. Folkerd, C. Messiou, L. R. Molife, G. Maier, E. Thompson, et al. Selective Inhibition of CYP17 With Abiraterone Acetate Is Highly Active in the Treatment of Castration-Resistant Prostate Cancer J. Clin. Oncol., August 10, 2009; 27(23): 3742 - 3748. [Abstract] [Full Text] [PDF]
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M. J. Schlumberger, R. Elisei, L. Bastholt, L. J. Wirth, R. G. Martins, L. D. Locati, B. Jarzab, F. Pacini, C. Daumerie, J.-P. Droz, et al. Phase II Study of Safety and Efficacy of Motesanib in Patients With Progressive or Symptomatic, Advanced or Metastatic Medullary Thyroid Cancer J. Clin. Oncol., August 10, 2009; 27(23): 3794 - 3801. [Abstract] [Full Text] [PDF]
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E. Poplin, Y. Feng, J. Berlin, M. L. Rothenberg, H. Hochster, E. Mitchell, S. Alberts, P. O'Dwyer, D. Haller, P. Catalano, et al. Phase III, Randomized Study of Gemcitabine and Oxaliplatin Versus Gemcitabine (fixed-dose rate infusion) Compared With Gemcitabine (30-minute infusion) in Patients With Pancreatic Carcinoma E6201: A Trial of the Eastern Cooperative Oncology Group J. Clin. Oncol., August 10, 2009; 27(23): 3778 - 3785. [Abstract] [Full Text] [PDF]
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J. H. Schiller, T. Larson, S.-H. I. Ou, S. Limentani, A. Sandler, E. Vokes, S. Kim, K. Liau, P. Bycott, A. J. Olszanski, et al. Efficacy and Safety of Axitinib in Patients With Advanced Non-Small-Cell Lung Cancer: Results From a Phase II Study J. Clin. Oncol., August 10, 2009; 27(23): 3836 - 3841. [Abstract] [Full Text] [PDF]
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W. J. Gradishar, D. Krasnojon, S. Cheporov, A. N. Makhson, G. M. Manikhas, A. Clawson, and P. Bhar Significantly Longer Progression-Free Survival With nab-Paclitaxel Compared With Docetaxel As First-Line Therapy for Metastatic Breast Cancer J. Clin. Oncol., August 1, 2009; 27(22): 3611 - 3619. [Abstract] [Full Text] [PDF]
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